The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention.

The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.

Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.

Physical activity as an average weekly energy expenditure (METS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.

Postpartum weight retention at 18 months [ Time Frame: 2 years ]

The difference between the weight at 18 months postpartum and the prepregnancy weight (or early pregnancy weight). Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum

(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum

Behavioral: electronic intervention during pregnancy and postpartum

Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention

Other Names:

Behavior modification intervention for pregnancy

Behavior modification intervention for postpartum

Prevention of excessive gestational weight gain

Prevention of postpartum weight retention

Electronically-mediated behavioral interventions

Experimental: electronic intervention group 1

(e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm

Behavioral: electronic intervention during pregnancy

Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.

Other Names:

Behavior modification intervention for pregnancy

Prevention of excessive gestational weight gain

Electronically-mediated behavioral interventions

Placebo Comparator: Control

Behavioral: Control

Control women will receive non-weight related content during both time periods at the project website.

Other Name: Control group

Detailed Description:

This study seeks to expand the understanding of how to slow the accumulation of weight in childbearing women. The intervention goals are to decrease the prevalence of excessive pregnancy weight gain and mean weight retention in the first 18 months postpartum in socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will be randomly assigned to one of three groups: Intervention Group 1 will receive the intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2). Control women will receive non-weight related content during both time periods at the project website. The primary hypotheses for the randomized controlled trial are: H1: The proportion of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended by the IOM will be 33% less than the proportion of the women in the Control Group who gain excessively and H2: The Control Group will have a higher mean weight retention at 12 months postpartum than Intervention Groups 1 and 2.

Eligibility

Ages Eligible for Study:

18 Years to 35 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Age 18 - 35 at the time of delivery

Consented at or before 20 weeks gestation

Intending to be available for a 24 months intervention

Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area)

Plan to carry the pregnancy to term

Plan to keep the baby

Read and understand English

Exclusion Criteria:

BMI < 18.5 kg/m2 and > 35.0 kg/m2.

Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form)

Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study

Participants will be excluded during screening if they report regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). "Regular use" is defined as "taking this medication most days of the week for the previous month"

Current treatment for eating disorder

Positive screening for bulimia

Weight loss of more than 15 pounds in the three months prior to pregnancy

Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 month. Revascularization is defined as bypass surgery or stints

Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or on remission for less than 5 years

Blood pressure criterion

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331564